Tamper Evident Point of Containment, Inventory and Accountability System and Method

ABSTRACT

The system in at least one embodiment provides a tamper evident specimen sample lock that in a further embodiment includes an embedded storage medium. They system and method in at least one embodiment allows for efficiently and securely creating, maintaining, identifying, tracking, and controlling inventories (either prospective or retrospective) of biological and chemical sample containers and their contents, while eliminating potential loss and degradation associated with handling the samples. The system in at least one embodiment provides a sample container tray or cryogenic box having one or more integrated RFID readers within an associated smart lid that sense RFIDs associated with the individual samples thereby eliminating the need to remove, visually inspect, and/or handle the samples.

This application is a continuation application of U.S. patentapplication Ser. No. 15/149,453, filed on May 9, 2016 and issued as U.S.Pat. No. 9,858,457, which is a continuation application of U.S. patentapplication Ser. No. 13/814,600, filed on Apr. 11, 2013 and issued asU.S. Pat. No. 9,336,669, which was the National Stage of InternationalApplication No. PCT/US2011/046982, filed on Aug. 8, 2011, which claimedthe benefit of U.S. Provisional Patent Application Ser. No. 61/401,178filed Aug. 6, 2010. The International Application No. PCT/US2011/046982was published on Feb. 2, 2012. The above patent applications are herebyincorporated by reference.

I. FIELD OF THE INVENTION

The present invention in at least one embodiment relates to a system andmethod for providing an indication of whether a specimen sample has beentampered with or otherwise accessed. The present invention in at leastone embodiment relates to a system and method for identifying andtracking specimen samples currently in storage conditions withincontainers, as well as, prospectively collected specimen samples. Moreparticularly, the present invention in at least one embodiment relatesto a tamper evident RFID inventory and accountability system and methodfor efficiently identifying and tracking biological and chemicalspecimens while being stored.

II. BACKGROUND OF THE INVENTION

Biological and chemical sample containers are commonly used in themedical, chemical, bioscience and drug research and testing industries.These containers are typically made of plastic, glass, or a similarnon-reactive material and cover a range of sizes and types. However,smaller vials such as, 0.5 mL, 1 mL, 1.5 mL, 1.8 mL, and the like, arewidely used in the medical, chemical, bioscience and drug research andtesting industries. In these industries, unique specimen samples (forexample, blood or urine in the drug testing industry) are maintained inindividual vials. The individual vials are often stored within acontainer such as a box that typically holds up to 100 vials per box.Laboratories and research facilities are two examples where the missionrequires storage of specimen samples that number into the tens ofthousands or hundreds of thousands in incubators, refrigerators,freezers, cryogens, and similar storage devices with increasing numbersof samples projected for collection, use and storage. In aggregate,these samples number into the millions. Therefore, given the number ofsamples that are stored it is imperative that each specimen sample isreliably identified and tracked in order to maintain the integrity ofthe research and testing, and to meet applicable reporting requirements.

Some prior specimen identification and tracking systems have includingprinted (written or handwritten) labels that require visual inspection,or a unique bar code along the side of the container that is typicallylocated and scanned using a hand held optical scanner. The printed labelsystems require users to remove the trays from storage and remove thespecimen vials from the tray in order to identify and track thespecimen. The bar code labeling systems utilize a light beam emittedfrom the scanner to “read” the bar code label. Because the relationshipof the single-use test device or biological or chemical sample containeris by nature transitory and such items are either discarded followinguse or cleansed by some process, prior systems did not provide amechanism for positive tracking of the sample or test object other thanby barcode or handwritten labels. Handwritten, adhesive label and barcode technology requires positive line-of-sight and may be adverselyaffected by the contents of the sample, reagents and/or by physicalhandling of the test device or specimen container which may degrade thelabel such that it cannot be read by human eye or an optical reader. Barcode technology also requires sample containers to be removed fromstorage and handled individually, resulting in lengthy inventoryprocesses that create a significant potential for loss or damage to thecontainer and/or specimens because of their removal from the storagedevice.

Securely and efficiently protecting samples against tampering andcontamination remains a critical concern. The vast majority of theexisting samples are stored insecurely in a manner prone to tamperingand contamination—often in vials having only a flip top, screw top, etc.that can be easily breached by unauthorized personnel. For example, acritical and urgent need exists to maintain a one-hundred percentinventory and accountability of all Biological and Select Agent andToxin (BSAT) samples in the Department of Defense (DoD) Inventory. Inaddition, mechanisms must be put in place to monitor and notify oftampering or unauthorized access to such samples. BSAT samples must besecured in a manner appropriate to guard against misuse, theft, loss oraccidental release. These inventory and security measures must beimplemented in a coordinated manner that balances security andefficiency with access to scientists for the legitimate use of BSAT. Thesame need applies to numerous biological science laboratories inhospitals, blood storage facilities, fertility clinics, etc., i.e.,anywhere inventory and accountability of valued or sensitive items arerequired at a moment's notice.

Increasing regulatory requirements by human and animal ethical usepolicies, as well as, state agency imposed requirements mandate accurateand efficient accountability of all specimens, prospective andretrospective. The increased requirements in addition to the mountingvolumes of samples requiring storage demands a significant amount ofadditional administrative work to efficiently, securely and accuratelyinventory and account for biological samples. Currently, most laboratorypersonnel simply write a coded sequence number on the sample containerdirectly or use an adhesive label to identify the contents. Limited byline-of-sight, the primary strategy to account for a sample is tophysically remove it from its current storage condition such as in anincubator at approximately 37 C or a freezer, count the vialsone-by-one, affirming that the label indicates a material exists in thecontainer. Multiple permutations on line-of-sight strategies tostreamline the inventory process are used. However, additionallimitations create significant inefficiencies. But these inefficienciescan be overcome by use of the present invention.

III. SUMMARY OF THE INVENTION

In at least one embodiment, the present invention provides a tamperevident sample locking device, including an elongated locking striphaving two ends that are foldable to mate with each other, wherein theelongated locking strip is made of a resilient material that provides aphysical indication of tampering and includes an opening capable ofreceiving and securely engaging the exterior surface of a specimensample container, wherein the opening is proximate the middle of theelongated locking strip; locking mechanisms substantially proximate bothends of the elongated locking strip, wherein the locking mechanismsfittingly engage with and lock to each other when the ends of theelongated locking strip are folded to mate with each other; wherein thespecimen sample container is securely locked within the elongatedlocking strip such that removal of the specimen sample containerprovides a physical indication of tampering on the elongated lockingstrip. In a further embodiment, the device includes a data storagedevice in the locking strip.

In at least another embodiment, the present invention provides a tamperevident sample locking device, including a central hub, wherein thecentral hub is capable of engaging an end of a specimen samplecontainer; multiple elongated locking members attached to the centralhub, wherein the multiple elongated locking members are capable ofengaging the exterior surface of the specimen sample container andinclude multiple locking structures longitudinally spaced along thelength of the locking members; and a locking collar having multiplelocking apertures, wherein the locking apertures are capable ofreceiving and securely engaging the exterior surface of a specimensample container, and receiving and locking the multiple lockingstructures of the multiple elongated locking members; wherein thespecimen sample container is securely locked within the elongatedlocking strip such that removal of the specimen sample containerprovides a physical indication of tampering on the elongated lockingstrip. In a further embodiment, the device includes a data storagedevice in the hub.

In at least another embodiment, the present invention provides a methodincluding writing information related to an individual sample to an RFIDdevice, wherein the RFID device is uniquely associated with the sample;placing the individual sample in a specimen container device, whereinthe specimen sample device is attached to the RFID device; writing anyupdated information to the RFID device; storing the specimen samplecontainer, wherein the specimen sample container is stored within anenvironment that maintains the integrity of the specimen sample; andinventorying the specimen sample container by interrogating the RFIDassociated with the specimen sample container.

In at least another embodiment, the present invention provides a methodfor maintaining, tracking, and identifying the integrity of a specimensample, the method including writing information related to a storedspecimen sample to an RFID device, wherein the RFID device is associatedwith the sample; removing the specimen sample from storage; placing andlocking the RFID device on a specimen sample container enclosing thespecimen sample; returning the specimen sample container to storage,wherein the specimen sample container is stored within an environmentthat maintains the integrity of the specimen sample; and inventoryingthe specimen sample container by interrogating the RFID associated withthe specimen sample container.

In at least a further embodiment, the present invention provides tamperevident sample locking device including an elongated locking striphaving two ends that are foldable to mate with each other, wherein theelongated locking strip is made of a resilient material that provides aphysical indication of tampering and includes an opening capable ofreceiving and securely engaging the exterior surface of a specimensample container; locking mechanisms disposed on the elongated lockingstrip, wherein the locking mechanisms fittingly engage with and lock toeach other when the ends of the elongated locking strip are folded tomate with each other; wherein the specimen sample container is securelylocked within the elongated locking strip such that removal of thespecimen sample container provides a physical indication of tampering onthe elongated locking strip.

In at least a further embodiment, the present invention provides atamper evident sample locking device including an elongated lockingstrip having two ends that are foldable to mate with each other, whereinthe elongated locking strip is made of a resilient material thatprovides a physical indication of tampering and includes means forreceiving and securely engaging an exterior surface of a specimen samplecontainer, wherein the means is proximate the middle of the elongatedlocking strip; locking mechanisms substantially proximate both ends ofthe elongated locking strip, wherein the locking mechanisms fittinglyengage with and lock to each other when the ends of the elongatedlocking strip are folded to mate with each other, and wherein thelocking mechanisms include openings and raised projections, wherein eachof the projections engage with and lock to at least one of openings; anRFID device connected to the elongated locking strip, wherein theelongated locking strip further includes at least one depression and theRIFD device is disposed within one or more of the at least onedepression; and at least one fault line, wherein the at least one faultline allows the elongated fastening strip to fold more easily.

In at least a further embodiment, the present invention provides atamper evident sample locking device including an elongated lockingstrip having two ends that are foldable to mate with each other, whereinthe elongated locking strip is made of a resilient material thatprovides a physical indication of tampering and includes means forreceiving and securely engaging an exterior surface of a specimen samplecontainer, wherein the means is proximate the middle of the elongatedlocking strip; locking apertures substantially proximate both ends ofthe elongated locking strip, wherein the locking apertures align suchthat a locking mechanism is capable of engaging the aligned lockingapertures; and a locking mechanism that fittingly engages with and locksto the locking apertures such that both ends of the elongated lockingstrip are securely fastened to each other.

In at least a further embodiment, the present invention provides asystem including a locking collar means; and a container cap securingmeans; wherein the locking collar means is capable of engaging thecontainer cap securing means in a manner that securely locks a containerwithin the container cap securing means such that the container cannotbe removed without providing a physical indication of tampering.

IV. BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an example of a tamper evident sample locking devicein accordance with an embodiment of the present invention.

FIG. 2 illustrates an example of a tamper evident sample locking devicein accordance with an embodiment of the present invention as illustratedin FIG. 1 in use.

FIG. 3 illustrates an example of an alternative embodiment of a tamperevident sample locking device in accordance with an embodiment of thepresent invention.

FIG. 4A illustrates an example of an alternative embodiment of a tamperevident sample locking device in accordance with an embodiment of thepresent invention.

FIG. 4B illustrates an example a locking collar of the alternativeembodiment of the tamper evident sample locking device as illustrated inFIG. 4A.

FIG. 4C illustrates another view of the tamper evident sample lockingdevice in accordance with an embodiment of the present invention asillustrated in FIG. 4A.

FIG. 4D illustrates an example of the tamper evident sample lockingdevice in accordance with an embodiment of the present invention asillustrated in FIG. 4A, in use.

FIG. 5 illustrates an example of an embodiment of a smart samplecontainer tray and lid in accordance an embodiment of the presentinvention.

FIG. 6 illustrates a method of maintaining, tracking and identifying theintegrity of a specimen in accordance with an embodiment of the presentinvention.

FIG. 7 illustrates an alternative method of maintaining, tracking andidentifying the integrity of a specimen in accordance with an embodimentof the present invention.

Given the following enabling description of the drawings, the apparatusshould become evident to a person of ordinary skill in the art.

V. DETAILED DESCRIPTION OF THE DRAWINGS

While the present invention is susceptible of embodiments in variousforms, there is shown in the drawings and will hereinafter be describedsome exemplary and non-limiting embodiments, with the understanding thatthe present disclosure is to be considered an exemplification of theinvention and is not intended to limit the invention to the specificembodiments illustrated.

The present invention provides different embodiments for devices,methods and systems for creating, maintaining, identifying, tracking,and controlling inventories of biological and chemical samplescontainers and their contents at the point of containment. In at leastsome embodiments, the present invention provides a tamper evident systemand method that is capable of use in a retrofit implementation, while infurther embodiments portions of the system are incorporated into theconstruction of the sample container. In at least some embodiments, thepresent invention provides a tamper evident RFID inventory tracking andaccountability system and method. In at least some embodiments, thepresent invention provides a sample lock that includes an embeddedstorage medium, such as an RFID chip, integrated circuit (IC), orcomparable technology, that allows the sample to be quickly and easilyidentified, tracked and accounted for without the need to remove,visually inspect, and/or handle the sample. In at least someembodiments, the present invention provides a sample container tray orbox having one or more integrated RFID transceivers that interrogate andreport the RFIDs associated with the individual samples.

In at least one embodiment, the present invention provides a tamperevident sample locking device, as illustrated in FIG. 1. The samplelocking device 100 includes a locking strip 110 having an opening (orlocking collar) 120 that is sized and designed to fit over the top (orbottom) of a specimen sample container 170 and fittingly engage thesidewall or cap 175 of the container 170 such that the ends of thelocking device 100 can be folded to engage each other and fasten into alocked position. In at least one embodiment, the opening 120 issubstantially centered on the locking strip 110. Based on thisdisclosure, it should be understood that cap 175 and container 170 canbe a variety of combinations that are used for storing samples. Thelocking strip 110 is preferably made of a resilient material, e.g.,polypropylene, resin, or a similar substantially rigid polymer. Thematerial should provide a clear indication of tampering in the event ofbeing broken, stretched, cut, torn, burned, and the like. The lockingstrip 110 may include one or more depressions 130A, 130B that are sizedand designed to receive and secure an optional embedded data storagemechanism 135, e.g., an RFID chip, integrated circuit, transceiver, orsimilar technology that is capable of receiving and storing data, aswell as transmitting data when queried. The optional embedded datastorage mechanism 135 may be affixed permanently or semi-permanentlyeither during the manufacturing process or prior to deploying the samplelocking device 100. In embodiments wherein the data storage mechanism135 is an RFID chip, the RFID includes an integrated circuit (IC) and anantenna. The IC stores and processes information, modulates anddemodulates radio frequency (RF) signals, and performs other specializedor programmable functions. The antenna receives and transmits RFsignals. The RFID chip may be passive, active or battery assistedpassive (BAP). A battery is included in active and BAP embodiments. TheRFID chip may be designed so that the antenna, chip, battery, and/orwiring break when the RFID chip is tampered with. The RFID chip maythereby provide an indication of tampering, because of itsinoperability.

The embedded data storage mechanism 135 can be programmed to store andtransmit a variety of information related to the sample to an associateddata reader (not shown), e.g., an RFID reader or transceiver. Theembedded data storage mechanism 135 may also be designed to provide anelectronic indication of tampering upon the opening of the lockingdevice 100. The locking strip 110 includes locking mechanisms 140, e.g.,raised notches having projections, which securely engage with apertures150 to lock the sample locking device 100 around the cap 175 of aspecimen sample container 170. Based on this disclosure, it should beappreciated that locking mechanisms can take a variety of structures.The locking strip 110 may also include optional depression or faultlines 160 that improve the deployment of the sample locking device 100by making it easier to bend and lock the locking strip 110 around thesample container. Damage or removal of the sample locking device 100will result in a traceable and/or noticeable alteration of the device100. Once locked, the sample locking device 100 ensures that the samplecontainer remains closed and cannot be opened without presenting a clearphysical and/or electronic indication of tampering.

As illustrated in FIG. 2, the sample locking device 200 is placed overthe top or bottom of a specimen sample container 270 by inserting thesample container into opening (or locking collar) 220. The lockingdevice 200 is then slid along the wall of the specimen sample container270 until the locking device 200 fittingly and securely engages thespecimen sample container 270. The ends of the locking strip 210 arethen folded snugly over the end (top or cap) of the specimen samplecontainer 270, e.g., along optional depression or fault lines 260, untilthe ends meet. The locking strip 210 may be provided with one or moredepressions (not shown) that allow the locking strip 210 to fit aroundand securely enclose the embedded data storage mechanism 235. Thelocking mechanisms 240 are then inserted into the apertures 250 untilthe ends of the locking strip 210 securely abut each other and thelocking mechanisms are securely and permanently engaged. Once lockedaround a specimen sample container 270, the sample locking device 200can only be removed by breaking, stretching, cutting, tearing, burning,and/or otherwise destroying one or more of the components of the samplelocking device 200 and thereby restricts access to the interior of thespecimen sample container 270. Upon the opening of or attempted openingof the specimen sample container 270, the sample locking device 200 willbe destroyed and/or provide clear physical evidence of tampering. Thelocking device in at least one further embodiment also provides anelectronic indication of tampering via the embedded data mechanism. Thelength of the locking strips 210 can be a variety of lengths as long asthe opposing ends of the locking strip 210 can engage each other. Thesample locking device 200 thereby ensures that the sample container cap275 remains closed and cannot be opened without presenting a clearphysical and/or electronic indication of tampering.

FIG. 3 illustrates another alternative embodiment of a tamper evidentsample locking device of the present invention. The sample lockingdevice 300 provides similar functionality and operability as the deviceillustrated above with respect to FIGS. 1 and 2. However, the lockingelement 330 is embodied in a separate part that includes an optionalembedded data mechanism 335 and locking mechanisms 340. The samplelocking device includes a locking strip 310 having an opening (orlocking collar) (not shown) that is sized and designed to fit over thetop (or bottom) of a specimen sample container 370 and fittingly engagethe sidewall or cap 375 of the container 370 such that the end of thelocking device 300 can be folded to engage each other and fasten into alocked position. The locking strip 310 is preferably made of a resilientmaterial, e.g., polypropylene, resin, or a similar substantially rigidpolymer. The material should provide a clear indication of tampering inthe event of being broken, stretched, cut, torn, burned, and the like.The locking strip 310 may include one or more locking apertures 350 thatare sized and designed to receive and secure locking mechanisms 340. Thelocking mechanisms 340 include a structure, e.g., a projection, conicalelement, ball-like element, or the like, that passes through the lockingapertures 350 and fittingly secures the ends of the locking strip 310together. The locking mechanism 340 may also include an embedded datamechanism 335. The embedded data mechanism 335 may be placed within oneor more option depressions (not shown) within the locking mechanism 340.The embedded data mechanism 335 may also be molded within the lockingmechanism 335. The locking strip 310 thereby securely locks the samplelocking device 300 around the cap 375 of a sample container 370. Basedon this disclosure, it should be appreciated that locking mechanisms cantake a variety of structures. The locking strip 310 may also includeoptional depression or fault lines 360 that improve the deployment ofthe sample locking device 300 by making it easier to bend and lock thelocking strip 310 around the sample container. Damage or removal of thesample locking device 300 will result in a traceable and/or noticeablealteration of the device 300. Once locked, the sample locking device 300ensures that the sample container remains closed and cannot be openedwithout presenting a clear physical and/or electronic indication oftampering.

FIGS. 4A-4D illustrate an alternative embodiment of a tamper evidentsample locking device of the present invention. FIG. 4A illustrates asample locking device 400 having a central hub 410 connected to multiplelegs or lock members 430A, 430B, 430C, 430D. The hub 410 in a furtheralternative embodiment includes an optional embedded data storagemechanism 420. Locking members 430A, 430B, 430C, 430D are elongated andinclude multiple locking structures 432A, 432B, 432C, 432D,respectively. The locking members 430A, 430B, 430C, 430D may also,respectively, include tips 435A, 435B, 435C, 435D that are sized anddesigned to improve deployment. The locking structures of lockingmembers 430A, 430B, 430C, 430D are sized and designed to pass throughand lock within the locking apertures 445 of locking collar 440,illustrated in FIG. 4B. The locking apertures 445 are sized and designedto allow the raised structures 432A, 432B, 432C, 432D to pass throughand be locked within the locking apertures 445. The locking structures432A, 432B, 432C, 432D may include, for example, but are not limited to:ball-like structures, barbs, teeth, arrowheads or conical shapedmembers, concave and flat structures, conical structures, and the likethat pass only one-way through the locking apertures 445. For example,the locking apertures may embody inverted cone-like structures thatallow the raised structures 432A, 432B, 432C, 432D to pass throughcone-like structure via the wide end of the cone such that the lockingstructures 432A, 432B, 432C, 432D are locked in position once they passthrough small end of the cone.

The sample locking device 400 and locking collar 440 are preferablyformed of a resilient but pliable material, e.g., polypropylene, resin,or a similar pliable rigid polymer. The material should be resilientenough in the data storage alternative embodiments to protect theoptional embedded data storage mechanism, but pliable enough to allowthe locking members to bend such that they can be drawn to fit snuglyaround the sample container 470 having a cap 275, as illustrated in FIG.4D. The material should provide a clear indication of tampering in theevent of being broken, stretched, cut, torn, burned, and the like. Thelocking collar 440 is also sized and designed to fittingly and securelyengage the sample container 470 having cap 475 as illustrated in FIG.4D. The locking collar 440 should be pliable enough to flex or stretcharound the sample container 470 but should have enough tension be securearound the sample container 470. The locking collar 440 may embody avariety of arrangements including high tensile bands, accordion-likerings, crisscrossed rings, and the like. In some embodiments, thelocking collar 440 is formed with the locking members 430A, 430B, 430C,430D. In other embodiments, the locking collar 440 is attached to orincorporated into the specimen container 470. In further embodiments,the central hub 420 is attached to the sample container cap 475.

As illustrated in FIG. 4D, the sample locking device is deployed bysliding the locking collar 440 from one end (such as the bottom) andalong the wall of the sample container 470 until the locking collar 440fittingly and securely engages the sample container 470. In analternative embodiment, the locking collar 440 is wrapped around thesample container 470. The central hub 410 is then placed over the cap475 (or bottom) of the sample container 470. The locking members 430 arethen bent along the wall of the sample container 470 and passed throughthe locking apertures 445. The central hub 410 (and embedded datastorage medium) is secured over the cap 475 of the sample container 470and the locking members 430 are tightened within the locking collar 440until the sample locking device 400 is fittingly and securely engagedwith the sample container 470. Once locked, the sample locking device400 can only be removed by breaking, stretching, cutting, tearing,burning, and/or otherwise destroying one or more of the components ofthe sample locking device 400. The sample locking device 400 therebyensures that the sample container cap 475 remains closed and cannot beopened without presenting a clear physical and/or electronic indicationof tampering depending on the embodiment.

In further alternative embodiments, the locking collar as discussedabove with respect to FIGS. 1-4D may include a plurality of teeth thatextend from the locking collar to help secure the locking collar ontothe specimen sample container. For example, the teeth may extend fromthe locking collar in a direction that is substantially longitudinal andinward with respect to the specimen sample container such that the teethabut the specimen sample container. The teeth allow the locking collarto only be moved in one direction, i.e., onto the specimen samplecontainer, such that when the locking collar is in the “locked” positionattempts to remove, reverse, or back off the locking collar the teeth“bite” into the specimen sample container and prevent the locking collarfrom being removed.

While the preferred embodiments of the above-described invention includean embedded data storage mechanism, the invention is capable of beingdeployed without the use of such a mechanism. In embodiments that do notinclude a data storage mechanism, the sample locking device when placedover the cap would still prevent access to the sample container andprovide a clear physical indication of tampering. Those embodimentswould therefore still function as an effective tamper evident samplelocking device. However, those embodiments would not provide anelectronic indication of tampering.

FIG. 5 illustrates another aspect of the tamper evident sample lockingdevice of the present invention. A smart sample container tray such as acryogenic box 500 includes a bottom tray 510 and smart lid 520. Thebottom tray 510 includes an array of sample container holders 515 thatmay be sized and designed to hold a variety of standard sample containerholders. For example, the cryogenic box may be of a standard size, e.g.,4.875 inches×4.875 inches×1.3125 inches, or 5.2 inches×5.25 inches×2inches, or 3 inches×3 inches×2 inches. The array of sample containerholders 515 may be arranged, e.g., 9 by 9 or 10 by 10, in order tosecurely hold a standard number of sample containers, e.g., 81 or 100.The smart lid 520 is sized and designed to engage with the cryogenic box510 in a cooperating fashion such that the sample containers aresecurely held within the array of sample container holders 515 insidethe cryogenic box 510. The smart lid 520 includes one or more embeddedtransceivers 525, e.g., an RFID reader, which is capable of receivingand transmitting data. The one or more embedded transceivers 525 shouldbe tuned and arranged to communicate with all of the desired samplesstored within the cryogenic box 500. The embedded transceiver 525 may beprogrammed to transmit data according to a schedule or upon beingqueried or instructed by an associated computer (not shown) to initiateinterrogation and receive reporting signals from the associated embeddedtransceiver 525. The embedded transceiver 525 may communicate with anassociated computer on a variety of known wireless and/or wiredcommunication platforms (e.g., wire harness or bus) and protocols, asappropriate. The placement of the embedded transceiver 525 thereforeallows samples to be stored, maintained, identified, tracked, andreported without having to remove the samples from storage, handle thesamples, visually inspect the samples, etc. Further, given the vastnumber of samples that are often stored and the heightened tracking andreporting requirements, at least one tracking embodiment significantlyimproves the integrity, efficiency and accuracy of the storing,maintaining, identifying, tracking, and reporting requirements.

The cryogenic box 500 in at least one embodiment is formed of a suitableresilient and temperature resistant material that is appropriate for theintended use of the cryogenic box 500. The materials should beappropriate to withstand very low temperatures (for example,temperatures associated with use in liquid nitrogen) and/or very hightemperatures (for example, temperatures associated with use inincubators) and the like without presenting a risk of deterioration tothe samples contained within the cryogenic box 500 or the cryogenic box500 itself. The cryogenic box 500 is therefore suitable for use within avariety of storage and testing environments including storage freezers,refrigerators, incubators, etc.

In some embodiments, the smart sample box or cryogenic box may notinclude a smart lid. While the embedded transceiver 525 is illustratedas being contained with the smart lid 520, other arrangements of theembedded transceiver 525 may also be utilized without departing from theinvention, including placing the embedded transceiver within the bottomtray 510, beneath the bottom tray 510, above the top 520, or within veryclose proximity to the samples such that the communication can beestablished. In other embodiments, the embedded transceiver 525 may beattached to or embedded in a mat suitable for use within the storageenvironment such as within a refrigerator or cryogenic freezer. The matcan then be placed within the storage device, e.g., on the shelf of arefrigerator, such that the embedded transceiver 525 can sense signalsfrom within storage trays placed on the shelf.

FIG. 6 illustrates a method of maintaining, tracking and identifying theintegrity of a specimen sample in accordance with the present invention.The method 600 begins at 602 by writing information related to thesample to an RFID device that is uniquely associated with the individualsample, i.e., a data device that is attached to the sample container.The information may include, for example, the date, a uniqueidentification of the sample container (vial), text, research data, etc.At 604, placing and locking the specimen sample in the specimen samplecontainer having the RFID device attached thereto. At 606, writing anyupdated information to the RFID device. This updated information mayinclude, for example, the date, time, sample lot size, etc. At 608,storing the sample container in an appropriate environment to maintainthe integrity of the specimen sample. At 610, sending the specimensample container to a laboratory for analysis. At 612, inventorying thespecimen sample container by interrogating the RFID associated with thespecimen sample container.

The method of present invention provides a reliable and accuratespecimen sample maintenance, tracking and identifying method thatensures the integrity of the specimen samples during storage, testingand/or transport. The method utilizes an embedded data storage mechanismthat is capable of receiving and storing data, as well as transmittingdata when queried. The RFID provides a means of continual and instantquerying and verification of the specimen sample. In addition tospecimen vials other suitable container may also be used including, forexample, Petri dishes, flasks, bottles, test-tubes, re-sealable plasticbags, pharmaceutical type storage containers, bins, clam-shell cases,bottle stoppers or corks and plastic cassettes.

FIG. 7 illustrates an alternative method of maintaining, tracking andidentifying the integrity of a specimen sample in accordance with thepresent invention. The method 700 is suitable for “retro-fitting” astored sample with an RFID device of the present invention. The method700 begins at 702 by writing information related to a stored specimensample to an RFID device, i.e., a specimen sample locking device havingan embedded data storage device. The information may include, forexample, the date, a unique identification of the sample container(vial), text, research data, etc. At 704, removing the specimen samplefrom storage. At 706, placing and locking the specimen sample in thespecimen sample container within the RFID specimen sample lockingdevice. At 708, writing any updated information to the RFID device. Thisupdated information may include, for example, the date, time, sample lotsize, etc. At 710, returning the specimen sample container to storage inan appropriate environment to maintain the integrity of the specimensample. At 712, analyzing the specimen sample, wherein the analysis mayrequire sending the specimen sample container to a laboratory. At 714,inventorying the specimen sample container by interrogating the RFIDassociated with the specimen sample container.

An alternative embodiment includes using the above-described embodimentsto secure sample containers. An existing sample container is removedfrom storage, for example, as part of an inventory. Over the containeris slid the collar of one of the above-described locking devices. Thecollar engages and/or tightens around the container to resist removal.The locking components are attached or folded over the cap of the samplecontainer securing the cap to the sample container such that if thesample container is accessed, the locking device will need to bephysically manipulated and/or damaged resulting in a physical indicationthat access of the sample container has occurred. One particularlyuseful application of this method is in situations where a chain ofcustody is desired.

In a further alternative embodiment, the embodiment depicted in FIGS.4A-4C is used as described in the previous paragraph; however, whenaccess of the sample container is desired, the hub 410 is physicallyremoved by, for example, cutting the locking members 430A, 430B, 430C,430D. After the researcher or other user is finished, they attach a newhub 410 to the previously used collar. In an embodiment where the hub410 includes a data storage mechanism, the data from the previous datastorage mechanism is transferred to the new data storage mechanism alongwith the annotation of access to the sample container.

The present invention in at least one embodiment can be added, i.e.,retrofitted, to existing sample containers to provide an efficient andeffective means for the identification, inventory, tracking andreporting of the samples. The ability to retrofit previously existinginventories with tamper-evident RFID locking devices providessignificant savings of time and resources related to the maintenance,inventory and reporting processes.

The present invention in a further embodiment utilizes an RFIDtransceiver and system which can actively or passively query on-demandor as programmed to report all or part of the data associated with theRFID embedded containers. The RFID chip is imprinted with identificationthat can allow or disallow access to the stored data contingent on theuser-query and validation response. The system in at least oneembodiment reads from outside a storage container the presence of theRFID embedded sample containers. The system in a further embodiment isprogrammed to report an alert signal upon the detection of tampering ofa sample container.

The embedded data storage device of the present invention may also beused to provide electronic data generated entries that auto-fill anassociated electronic laboratory notebook, inventory record, inspectionreport or similar documentation. The embedded data storage device of thepresent invention may also communicate with and report the detection ofother devices including, for example, stir bars, incubators, etc., toreport start/stop time of incubation, stirring, experiment condition ordesignated experimental endpoint.

The exemplary embodiments described above may be combined in a varietyof ways with each other. Furthermore, the steps and number of thevarious steps illustrated in the figures may be adjusted from thatshown. It should be noted that the present invention may, however, beembodied in many different forms and should not be construed as limitedto the embodiments set forth herein; rather, the embodiments set forthherein are provided so that the disclosure will be thorough andcomplete, and will fully convey the scope of the invention to thoseskilled in the art. The accompanying drawings illustrate exemplaryembodiments of the invention.

The terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the invention. Asused herein, the singular forms “a”, “an” and “the” are intended toinclude the plural forms as well, unless the context clearly indicatesotherwise. It will be further understood that the root terms “include”and/or “have,” when used in this specification, specify the presence ofstated features, integers, steps, operations, elements, and/orcomponents, but do not preclude the presence or addition of one or moreother features, integers, steps, operations, elements, components,and/or groups thereof.

The corresponding structures, materials, acts, and equivalents of allmeans plus function elements in the claims below are intended to includeany structure, or material, for performing the function in combinationwith other claimed elements as specifically claimed. For example, collarmeans for receiving and securely engaging an exterior surface of aspecimen sample container include any of the above-described lockingcollars. An example of cap securing means for securing a cap to aspecimen sample bottle includes any of the above-described lockingmembers and/or hubs. The description of the present invention has beenpresented for purposes of illustration and description, but is notintended to be exhaustive or limited to the invention in the formdisclosed. Many modifications and variations will be apparent to thoseof ordinary skill in the art without departing from the scope and spiritof the invention. The embodiments were chosen and described in order tobest explain the principles of the invention and the practicalapplication, and to enable others of ordinary skill in the art tounderstand the invention for various embodiments with variousmodifications as are suited to the particular use contemplated.

As used above “substantially,” “generally,” and other words of degreeare relative modifiers intended to indicate permissible variation fromthe characteristic so modified. It is not intended to be limited to theabsolute value or characteristic which it modifies but rather possessingmore of the physical or functional characteristic than its opposite, andpreferably, approaching or approximating such a physical or functionalcharacteristic.

Those skilled in the art will appreciate that various adaptations andmodifications of the embodiments described above can be configuredwithout departing from the scope and spirit of the invention. Therefore,it is to be understood that, within the scope of the appended claims,the invention may be practiced other than as specifically describedherein.

1-8. (canceled)
 9. A method for communicating information regarding atleast one unique specimen sample vial uniquely associated with anembedded storage media to a transceiver in a tamper-evident samplelocking device, the method comprising: interrogating at least oneembedded storage medium associated with at least one specimen samplevial to inventory the specimen sample container and detect changes inspecimen sample vial stored data; receiving data from the at least oneembedded storage medium regarding the associated specimen sample vial byat least one transceiver embedded in the tamper-evident sample lockingdevice where the transceiver is tuned to communicate with the at leastone embedded storage medium; and sending data regarding the at least onespecimen sample vial into an inventory on a computer.
 10. The method ofclaim 9, further comprising alerting said transceiver when a noticeablealteration of said specimen sample vial has been detected by saidembedded storage medium.
 11. The method of claim 9, further comprisingthe transceiver interrogating and receiving data from said at least onespecimen sample vial and sending said data to the computer according toa schedule.
 12. The method of claim 9, further comprising thetransceiver interrogating and receiving data from said at least onespecimen sample vial and sending said data to the computer upon beingqueried or instructed by an external computer.
 13. A tamper evidentsample locking device comprising: a cryogenic box including a bottomtray having a plurality of sample container holders for secure placementof specimen sample vials equipped with an embedded storage mediumcapable of receiving, storing, and transmitting data; a smart lid sizedand designed to cooperatively engage with said cryogenic box; and atleast one transceiver tuned to electronically communicate with saidembedded storage medium and capable of interrogating at least oneembedded storage medium to receive data, said at least one transceiverconfigured to communicate with an external transceiver.
 14. The tamperevident sample locking device of claim 13, wherein said at least onetransceiver is embedded within the smart lid.
 15. The tamper evidentsample locking device of claim 13, wherein said at least one transceiverincludes a radio-frequency identification device.
 16. The tamper evidentsample locking device of claim 13, wherein the embedded storage mediumincludes a radio-frequency identification device.
 17. The tamper evidentsample locking device of claim 13, wherein said at least one transceiveris programmed to transmit data according to a schedule or upon beingqueried or instructed by an external computer to initiate interrogationand send a reporting signal to the external computer.
 18. The tamperevident sample locking device of claim 13, wherein said cryogenic box ismade of a suitable material to withstand low temperatures.
 19. Thetamper evident sample locking device of claim 13, wherein saidtransceiver is located in said bottom tray.
 20. A tamper evident storagesystem comprising: a storage environment, at least one storage containercontaining at least one unique specimen sample stored in a vial equippedwith an embedded storage medium; a transceiver tuned to electronicallycommunicate with said embedded storage medium and capable ofinterrogating said embedded storage medium to receive said data, saidtransceiver located within the storage environment in sufficiently closeproximity to establish communication with said embedded storage medium.21. The storage system of claim 20, further comprising a mat, whereinsaid transceiver is embedded within said mat, said mat made of amaterial capable to withstand the conditions of the storage environment.22. The storage system of claim 20, wherein said transceiver isprogrammed to transmit data according to a schedule or upon beingqueried or instructed by an external computer to initiate interrogationand send reporting signals to the external computer.
 23. The storagesystem of claim 20, wherein said transceiver includes a radio-frequencyidentification device.
 24. The storage system of claim 20, wherein saidembedded storage medium includes a radio-frequency identificationdevice.
 25. The storage system of claim 20, wherein said transceiver isconfigured to be in electronic communication with a plurality ofembedded storage media distributed in a plurality of storage containerslocated within the storage environment.